Sun Pharma Recalls Levetiracetam Extended Release Tablets for Dissolution Failure
Sun Pharma Global Fze is recalling 3,263 bottles of Levetiracetam extended release tablets because they failed to meet dissolution specifications at the 6-month time point.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) without reported injuries or illnesses, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Sun Pharma Global Fze is voluntarily recalling 3,263 bottles of Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only. The product was manufactured by Sun Pharmaceutical Ind. Ltd in Gujarat, India, and is identified by NDC Number 47335-576-86, Lot # JKN0249A, with an expiration date of 02/2016.
The recall was initiated because the affected tablets failed to meet dissolution specifications at the 6-month time point. Dissolution testing ensures that the medication releases the active ingredient at the intended rate; failure to meet these specifications may affect the drug's performance.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions.
The recalled product
- Product
- Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86
- Manufacturer
- Sun Pharma Global Fze
- Category
- Drug — Anticonvulsant
- Hazard
- Affected units
- 3,263
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: JKN0249A Exp 02/2016
Distribution
Distributed nationwide across the United States.
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